483
Janssen Biologics B.V.FDA 483 - Janssen Biologics B.V.
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Record Details
During an inspection from July 7-11, 2014, Janssen Biologics B.V. in Leiden, Netherlands, a drug substance manufacturer, was cited for inadequate investigations into batch failures. The firm failed to extend investigations of microbiological contaminations in bioreactor assemblies to other associated batches or drug substances, indicating a significant lapse in their quality system.
- Company
- Janssen Biologics B.V.
- Product Type
- Drugs
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ID · 548da985-9cd1-447d-9554-a699671301e8